NMPA (CFDA) Updates

July 9, 2020

NMPA is Revising Clinical Trial Approval Catalog

As innovative devices and first-of-kind products enter China market, NMPA seeks to strengthen the clinical trial approval requirements for certain devices. Not all of them require NMPA clinical approval to […]
July 8, 2020

In One Day, Two AI Diagnostic Software Go into NMPA Fast-Track Channel

NMPA granted fast-track channel status to two domestic AI-infused software on June 29, 2020: Innovation Status Zhiyuan Huitu: Assistance software for fundus diagnosis Priority Review Status Hangzhou Yitu: Assistance software […]
July 2, 2020

Edwards Lifesciences’ Transcatheter Aortic Valve System Obtained NMPA Innovation Approval

NMPA granted Innovation Approval to Edwards Lifesciences’ Transcatheter Aortic Valve System on June 8. It is the 14th device obtained such approval in 2020. Balloon Technology The product includes transcatheter […]
June 22, 2020

NMPA Updates: Four Orthopedic Guidelines Published in One Day

NMPA issued four orthopedic guidelines on June 9, 2020 to guide manufacturers for local type testing and regulatory approval. Registration Guideline on 3D printed acetabular cup products Registration Guideline on […]
June 22, 2020

China Real World Data Adoption: Faster Introduction for Urgently Needed Devices

 “Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone” was published by Hainan government on June 2, 2020. This important document mandates the qualification […]